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Unit Wise Question Bank

The document is a comprehensive question bank from the Lloyd Institute of Management & Technology (Pharm.) covering various units related to Quality Assurance, Quality Control, Good Manufacturing Practices, and documentation in the pharmaceutical industry. Each unit contains questions categorized into 2 marks, 7 marks, and 10 marks, addressing key concepts, definitions, procedures, and significance of various practices and regulations. The content aims to prepare students for assessments in pharmaceutical management and technology.

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Satyam Verma
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250 views5 pages

Unit Wise Question Bank

The document is a comprehensive question bank from the Lloyd Institute of Management & Technology (Pharm.) covering various units related to Quality Assurance, Quality Control, Good Manufacturing Practices, and documentation in the pharmaceutical industry. Each unit contains questions categorized into 2 marks, 7 marks, and 10 marks, addressing key concepts, definitions, procedures, and significance of various practices and regulations. The content aims to prepare students for assessments in pharmaceutical management and technology.

Uploaded by

Satyam Verma
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY (PHARM.

)
PLOT NO. 11, KNOWLEDGE PARK-II, GREATER NOIDA

QUESTION BANK

UNIT WISE QUESTION BANK

Unit-I: Quality Assurance and Quality Management Concepts


2 Marks Questions

1. Define Quality Assurance and Quality Control.


2. What is Total Quality Management (TQM)?
3. List the key elements of TQM.
4. What is the purpose of ICH guidelines?
5. Name the participants of ICH.
6. Define Quality by Design (QbD).
7. What are the tools used in QbD?
8. What are the benefits of ISO 9000 certification?
9. What does NABL accreditation stand for?
10. What are the steps for registration under ISO 14000?

7 Marks Questions

1. Explain the concept and importance of GMP.


2. Describe the harmonization process in ICH.
3. Explain the key elements of TQM.
4. Discuss ICH stability testing guidelines.
5. What are the principles and procedures of NABL accreditation?
6. Explain the Q-series guidelines of ICH in detail.
7. Discuss the benefits and elements of ISO 9000 and ISO 14000.
8. What are the various elements of the QbD program?
9. Explain the process of pharmaceutical quality assurance.
10. Describe the implementation of TQM in pharmaceutical industries.

10 Marks Questions

1. Explain ICH guidelines in detail with an emphasis on Q-series guidelines.


2. Describe the concept, principles, and implementation of TQM in pharmaceuticals.
3. Explain the role of Quality by Design (QbD) in pharmaceutical formulation.
4. Discuss the significance of NABL accreditation and its procedures.
5. Write a detailed note on the ISO certification process and its benefits in the
pharmaceutical industry.
LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY (PHARM.)
PLOT NO. 11, KNOWLEDGE PARK-II, GREATER NOIDA

QUESTION BANK

Unit-II: Organization, Personnel & Premises


2 Marks Questions

1. What are the responsibilities of pharmaceutical personnel?


2. Define Good Manufacturing Practices (GMP).
3. What is environmental control in pharmaceutical industries?
4. List the factors affecting contamination control.
5. Define the term "sanitation" in pharmaceutical premises.
6. What are the requirements for sterile area maintenance?
7. Define purchase specifications of raw materials.
8. What is the significance of plant layout in pharmaceuticals?
9. How is equipment selected in pharmaceutical manufacturing?
10. What are the essential qualities of warehouse storage areas?

7 Marks Questions

1. Explain the hygiene and training requirements for personnel in pharmaceutical industries.
2. Discuss the importance of plant layout in the pharmaceutical industry.
3. Describe the various methods for contamination control in pharmaceutical production.
4. Explain environmental control measures in pharmaceutical facilities.
5. What are the steps involved in the maintenance of sterile areas?
6. Describe the selection and maintenance of raw materials in pharmaceuticals.
7. Explain equipment selection and maintenance procedures.
8. Discuss the key considerations in pharmaceutical premises construction.
9. Describe personnel responsibilities in ensuring GMP compliance.
10. Explain the significance of sanitation and utilities in pharmaceutical industries.

10 Marks Questions

1. Explain in detail the design, construction, and maintenance of a pharmaceutical facility.


2. Discuss the importance of training, hygiene, and personnel record maintenance in GMP
compliance.
3. Explain in detail the methods for environmental and contamination control in
pharmaceutical premises.
4. Discuss the process of equipment selection, purchase, and maintenance in pharmaceutical
manufacturing.
5. Explain the layout and maintenance of sterile manufacturing areas.
LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY (PHARM.)
PLOT NO. 11, KNOWLEDGE PARK-II, GREATER NOIDA

QUESTION BANK

Unit-III: Quality Control & Good Laboratory Practices


2 Marks Questions

1. What is the role of Quality Control in the pharmaceutical industry?


2. Name the quality control tests for pharmaceutical containers.
3. Define Good Laboratory Practices (GLP).
4. What are the general provisions of GLP?
5. Name the important testing facility operations under GLP.
6. Define Test and Control Articles in GLP.
7. What are the components of a laboratory study protocol?
8. What is the significance of record-keeping in GLP?
9. List the criteria for disqualification of testing facilities.
10. Define the term "Nonclinical Laboratory Study."

7 Marks Questions

1. Explain the quality control tests for rubber closures and secondary packing materials.
2. Discuss the organization and personnel responsibilities under GLP.
3. Explain the different sections of a nonclinical laboratory study protocol.
4. Describe the facilities and equipment requirements for GLP compliance.
5. Explain the disqualification process of testing facilities under GLP guidelines.
6. Discuss the records and reports maintenance in GLP compliance.
7. Describe the significance of Quality Control in the pharmaceutical industry.
8. Explain the requirements for test and control articles under GLP.
9. What are the operational standards for testing facilities?
10. Explain the role of analytical methods in pharmaceutical Quality Control.

10 Marks Questions

1. Explain the concept and principles of Good Laboratory Practices (GLP).


2. Discuss the importance and procedures of record and report maintenance under GLP.
3. Explain in detail the different stages of a nonclinical laboratory study.
4. Discuss the significance of Quality Control in pharmaceuticals and its impact on drug
safety.
5. Explain the validation and qualification process in Quality Control testing.
LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY (PHARM.)
PLOT NO. 11, KNOWLEDGE PARK-II, GREATER NOIDA

QUESTION BANK

Unit-IV: Complaints, Documentation & Quality Audit


2 Marks Questions

1. Define pharmaceutical complaints.


2. What is the procedure for handling returned goods?
3. What is Quality Audit in pharmaceuticals?
4. Define Batch Formula Record.
5. What is the purpose of a Standard Operating Procedure (SOP)?
6. Define Master Formula Record.
7. What are the components of Quality Documentation?
8. What is the significance of distribution records?
9. Define the term "waste disposal" in pharmaceuticals.
10. What is the purpose of Quality Review?

7 Marks Questions

1. Explain the handling and evaluation of pharmaceutical complaints.


2. Discuss the role of documentation in pharmaceutical industries.
3. Write a short note on recall procedures and waste disposal.
4. Explain the types and significance of pharmaceutical reports.
5. Describe the different types of Quality Audits.
6. Explain the different sections of Batch Formula Record and Master Formula Record.
7. Discuss the importance of distribution records in pharmaceutical documentation.
8. What is the role of Standard Operating Procedures (SOPs) in pharmaceutical
manufacturing?
9. Explain the process of Quality Review in pharmaceuticals.
10. Describe the documentation requirements for GMP compliance.

10 Marks Questions

1. Explain in detail the significance and process of pharmaceutical documentation.


2. Discuss the importance of handling, evaluation, and recall of pharmaceutical products.
3. Explain in detail the different types of Quality Audits in pharmaceuticals.
4. Discuss the different elements of a Quality Review system.
5. Describe the purpose and process of pharmaceutical waste disposal.
LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY (PHARM.)
PLOT NO. 11, KNOWLEDGE PARK-II, GREATER NOIDA

QUESTION BANK

Unit-V: Calibration, Validation & Warehousing


2 Marks Questions

1. Define Calibration and Validation.


2. What are the general principles of calibration?
3. Define Validation Master Plan.
4. What is Good Warehousing Practice (GWP)?
5. Name the types of validation in the pharmaceutical industry.
6. What is analytical method validation?
7. Name the steps involved in pH meter calibration.
8. Define qualification of UV-Visible spectrophotometer.
9. What is the importance of materials management in warehousing?
10. Define the term "storage conditions" in Good Warehousing Practices.

7 Marks Questions

1. Explain the importance and scope of validation in pharmaceuticals.


2. Describe the qualification process of UV-Visible spectrophotometer.
3. Write a short note on Analytical Method Validation.
4. Discuss calibration procedures in pharmaceutical industries.
5. Explain the storage principles in warehousing.

10 Marks Questions

1. Explain in detail the various types of validation in the pharmaceutical industry.


2. Discuss the principles and procedures of Good Warehousing Practices.

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